Total clearances
8
2021-02-19 → 2025-10-27
Name variants in FDA filings: Circle Cardiovascular Imaging, Inc. / Circle Cardiovascular Imaging
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
4 |
2025-10-27 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
3 |
2023-12-07 |
| POK |
— |
— |
— |
1 |
2025-07-01 |
Filings
All 510(k) clearances (8)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-10-27 |
K251027 |
cvi42 Coronary Plaque Software Application |
QIH |
Class II |
Radiology |
| 2025-07-01 |
K250221 |
StrokeSENS ASPECTS Software Application |
POK |
— |
— |
| 2024-10-15 |
K242781 |
cvi42 Software Application |
QIH |
Class II |
Radiology |
| 2024-06-07 |
K241038 |
Cardiac CT Function Software Application |
QIH |
Class II |
Radiology |
| 2023-12-07 |
K232661 |
Myocardial Strain Software Application |
LLZ |
Class II |
Radiology |
| 2023-01-18 |
K222593 |
TruPlan Computed Tomography (CT) Imaging Software |
LLZ |
Class II |
Radiology |
| 2022-07-28 |
K213998 |
cvi42 Auto Imaging Software Application |
QIH |
Class II |
Radiology |
| 2021-02-19 |
K202212 |
TruPlan |
LLZ |
Class II |
Radiology |